1. Field of the Invention
This invention relates to a tamper evident protector cap for a pre-filled syringe barrel. More particularly, the invention relates to a cap for a syringe barrel containing a liquid medication therein for securely holding a closure in the tapered tip of the syringe barrel and serving as a tamper evident indicator.
2. Reported Developments
Pre-filled syringe barrels or cartridges containing injectable solutions therein are stoppered by elastomeric closures, such as soft rubber stoppers at the distal, tapered end thereof, while the proximal end of the barrels are closed by slidable plungers. The pre-filled syringe barrels or cartridges are sterilized, such as by autoclaving, and packaged ready for use.
It has been observed that during in-line processing, handling, and sterilizing the pre-filled barrels some elastomeric closures were missing from the tips of the barrels resulting in rejects. Also, during shipment of the finished product and handling by healthcare professionals some untipped barrels were observed which necessitated the discarding of batches containing failed samples. For product integrity a corrective measure was indicated to prevent the elastomeric closure from becoming dislodged from the tip of the barrel.
More importantly, it has also been recognized that untipped barrels (whether the damage occurred during shipment or handling) attracts the suspicion that the product was tampered with. Such possible tampering is a concern for both the FDA and the manufacturers who are required to insure safety, efficacy and product integrity.